Global Pharma Briefs: News from Asia, Europe and the USBy
A roundup of news from Japan (Takeda), the Netherlands (Gilead Sciences) and the US (GSK, Amarin, Apotex).
Takeda Receives FDA Warning Letter
Takeda has received a Warning Letter from the US Food and Drug Administration (FDA) for GMP violations for finished pharmaceuticals following an inspection of the company’s drug-manufacturing facility in Mitsui, Hikari, Yamaguchi, Japan. The FDA conducted the inspection from November 18 to Novermer 26, 2019.
In its Warning Letter, the FDA said the company’s quality unit did not take appropriate steps prior to resumption of aseptic manufacturing after a shutdown that included multiple activities that compromised cleanroom control. The agency also cited the company for inadequate aseptic processing simulations (media fills), poor aseptic behavior, inadequate controls over materials used in aseptic processing areas, and inadequate investigations into equipment malfunctions and not sufficiently addressing root causes or ensuring adequate scope into manufacturing investigations.
The FDA outlined a series of actions for the company to take, including: (1) a comprehensive assessment and remediation plan to ensure the company’s quality unit is given the authority and resources to effectively function; (2) a risk assessment of distributed products that did not provide adequate assurance of appropriate aseptic processing conditions; (3) a risk assessment of all contamination hazards with respect to the company’s aseptic processes, equipment, and facilities; (4) a plan to ensure appropriate aseptic practices and cleanroom behavior during production; and (5) a comprehensive and independent assessment of its system for investigating deviations and failures.
Source: US Food and Drug Administration
EMA OKs Kite’s CAR T Cell Therapy Mfg Facility in Europe
Kite, part of Gilead Sciences, has received approval from the European Medicines Agency for its manufacturing facility in Amsterdam for Yescarta (axicabtagene ciloleucel), a chimeric antigen receptor (CAR) T cell therapy. With this approval, the facility for manufacturing individualized cell therapies is now fully operational.
Yescarta is approved for the treatment of relapsed or refactory large B-cell lymphoma. The facility has the capacity to produce therapy for up to 4,000 patients per year. Kite has nearly 90 qualified treatment centers in 16 countries across Europe and Israel.
Kite has commercial cell-therapy manufacturing facilities in El Segundo, California and Amsterdam and clinical manufacturing in Santa Monica, California and Gaithersburg, Maryland. Kite is also building a third commercial cell-therapy manufacturing facility in Frederick County, Maryland, to expand the company’s ability to manufacture CAR T cell therapies. In addition to producing CAR T cell therapies, the clinical manufacturing network is also producing investigational T cell receptor therapies for evaluation in solid tumors. A new facility in Oceanside, California is also under construction and will be dedicated to the development and manufacturing of viral vectors, a starting material in the production of cell therapies.
Source: Gilead Sciences
GSK, Ideaya Form $170-M Oncology Pact in Synthetic Lethality
GlaxoSmithKline (GSK) and Ideaya BioSciences, a South San Francisco, California-based oncology-focused biopharmaceutical company, have entered into a strategic partnership in synthetic lethality, an emerging field in oncology, in a deal worth up to $170 million ($100 million upfront, $20-million equity purchase, and a potential $50-million cash option exercise fee).
The strategic partnership includes Ideaya’s synthetic lethality programs, MAT2A, Pol Theta, and Werner Helicase programs, which are projected to reach clinical trials within the next three years (as reported on June 16, 2020). Synthetic lethality is one of four core research focus areas for GSK in oncology. In synthetic lethality, cells tolerate the loss of single genes in isolation but not together in combination. When tumor-suppressor genes are functionally lost in cancer, this mode of action can be used to exploit tumor-specific vulnerabilities through new medicines for patients with cancer, according to information from the company.
Ideaya will receive a $100-million upfront cash payment, receive $20 million from an equity purchase of Ideaya common stock in a direct private placement, and receive a potential $50-million cash option exercise fee for the MAT2A program. Ideaya is also entitled to receive potential preclinical, clinical and sales milestones. Ideaya will lead the MAT2A program through early clinical development and is responsible for all costs of the MAT2A program prior to the GSK option exercise. Thereafter, Ideaya is responsible for 20% of global development costs.
In addition, Ideaya will receive a 50% US profit share and ex-US royalties for the MAT2A and Werner Helicase programs and is responsible for 20% of global development costs for licensed products being developed with GSK. Ideaya will receive global royalties for the Pol Theta program, and GSK will cover all research, development, and commercialization costs. GSK will be responsible for all commercialization activities and costs globally for licensed products.
The collaboration agreement is conditional upon customary conditions including regulatory review by the appropriate regulatory agencies under the Hart-Scott-Rodino Act.
Amarin, Apotex Settle Patent Dispute
Amarin, a Dublin, Ireland-based biopharmaceutical company focused on cardiovascular disease, has reached an agreement over a patent dispute with Apotex, a producer of generic drugs, regarding Amarin’s Vascepa (icosapent ethyl), a drug to treat hypertriglyceridemia (high levels of triglycerides).
Under the settlement, Apotex may not sell a generic version of Vascepa in the US until August 9, 2029 provided Amarin wins a federal appeal to reinstate Vascepa’s underlying patents that were struck down earlier this year (March 2020) by a federal district court. Apotex had previously filed an abbreviated new drug application with the US Food and Drug Administration (FDA) seeking approval of a generic form of Vascepa. Amarin is currently appealing a patent- invalidity ruling from a federal district court in Nevada made in favor of generic companies, Hikma Pharmaceuticals and Dr. Reddy’s Laboratories.
Amarin had resolved similar patent litigation over a generic version of Vascepa with Teva Pharmaceuticals in 2018 under which Teva agreed to not to sell its generic version of Vascepa in the US until August 9, 2029 or earlier under certain customary circumstances,
The agreement is subject to review by applicable federal authorities. In its settlement with Apotex, Amarin does not commit to supplying Apotex with icosapent ethyl at any time. Outside of the US, Amarin holds various patents and regulatory exclusivity rights to icosapent ethyl that are not part of this settlement and are not part of any current litigation, according to information from the company.